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Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan.

Publication ,  Journal Article
Steinle, NC; Pearce, I; Monés, J; Metlapally, R; Saroj, N; Hamdani, M; Ribeiro, R; Rosenfeld, PJ; Lad, EM
Published in: Am J Ophthalmol
July 2021

PURPOSE: To evaluate the effect of select baseline characteristics on geographic atrophy (GA) progression in eyes receiving intravitreal pegcetacoplan or sham. DESIGN: Phase 2 multicenter, randomized, single-masked, sham-controlled trial. METHODS: Patients with GA received 15 mg pegcetacoplan monthly or every other month (EOM), or sham injection monthly or EOM for 12 months. Primary efficacy endpoint was change in GA lesion size (square root) from baseline. Post hoc analysis evaluated the effects of age; gender; lesion size, focality, and location (extrafoveal vs foveal); pseudodrusen status; best-corrected visual acuity (BCVA); and low-luminance deficit (LLD) on GA progression at Month 12. RESULTS: Of 246 randomized patients, 192 with 12-month data were included in this analysis. Overall mean (standard deviation) change in lesion size (mm) was 0.26 (0.17) (P < .01), 0.27 (0.27) (P < .05), and 0.36 (0.21) in the monthly pegcetacoplan (n = 67), EOM pegcetacoplan (n = 58), and sham (n = 67) groups, respectively. In univariate analysis, patients with extrafoveal lesions (P < .001), BCVA ≥20/60 (P = .001), and larger LLD (P = .002) had greater mean changes in lesion size. Multivariate analysis confirmed significant association of extrafoveal lesions (P = .001) and larger LLD (P = .023) with GA progression. Monthly and EOM pegcetacoplan significantly reduced progression (P < .05) when controlling for these risk factors. CONCLUSIONS: Extrafoveal lesions and larger LLD are potential risk factors for GA progression. Pegcetacoplan treatment significantly controlled GA progression even after accounting for these risk factors.

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Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

July 2021

Volume

227

Start / End Page

116 / 124

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vision Disorders
  • Treatment Outcome
  • Single-Blind Method
  • Prospective Studies
  • Peptides, Cyclic
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Intravitreal Injections
 

Citation

APA
Chicago
ICMJE
MLA
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Steinle, N. C., Pearce, I., Monés, J., Metlapally, R., Saroj, N., Hamdani, M., … Lad, E. M. (2021). Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan. Am J Ophthalmol, 227, 116–124. https://doi.org/10.1016/j.ajo.2021.02.031
Steinle, Nathan C., Ian Pearce, Jordi Monés, Ravi Metlapally, Namrata Saroj, Mohamed Hamdani, Ramiro Ribeiro, Philip J. Rosenfeld, and Eleonora M. Lad. “Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan.Am J Ophthalmol 227 (July 2021): 116–24. https://doi.org/10.1016/j.ajo.2021.02.031.
Steinle NC, Pearce I, Monés J, Metlapally R, Saroj N, Hamdani M, et al. Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan. Am J Ophthalmol. 2021 Jul;227:116–24.
Steinle, Nathan C., et al. “Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan.Am J Ophthalmol, vol. 227, July 2021, pp. 116–24. Pubmed, doi:10.1016/j.ajo.2021.02.031.
Steinle NC, Pearce I, Monés J, Metlapally R, Saroj N, Hamdani M, Ribeiro R, Rosenfeld PJ, Lad EM. Impact of Baseline Characteristics on Geographic Atrophy Progression in the FILLY Trial Evaluating the Complement C3 Inhibitor Pegcetacoplan. Am J Ophthalmol. 2021 Jul;227:116–124.

Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

July 2021

Volume

227

Start / End Page

116 / 124

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vision Disorders
  • Treatment Outcome
  • Single-Blind Method
  • Prospective Studies
  • Peptides, Cyclic
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Intravitreal Injections